Home NDC 67091-354 Winco Foods Childrens Allergy Relief
Product NDC 67091-354
11-digit product format 670910354
Labeler code 67091
Product ID 67091-354_de7d1e71-4afe-4121-9d35-5b1c438ed2c3
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler WINCO FOODS, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-09
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Winco Foods Childrens Allergy Relief
Brand name suffix Dye Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049906 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-354-18 Winco Foods Childrens Allergy ReliefDye Free 1 in 1 CARTON SOLUTION 1 6 67091-354-18 Winco Foods Childrens Allergy ReliefDye Free 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-354 WINCO FOODS CHILDRENS ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WINCO FOODS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241121_a1367804-37c9-4906-858f-8feeb748d8d3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67091-354-18 67091035418 1 BOTTLE, PLASTIC in 1 CARTON (67091-354-18) / 118 mL in 1 BOTTLE, PLASTIC 2020-03-09 0000-00-00 No No Current